Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
This study has been completed.
Sponsor:
Cytochroma Inc.
Information provided by:
Cytochroma Inc.
ClinicalTrials.gov Identifier:
NCT00384098
First received: October 2, 2006
Last updated: June 25, 2007
Last verified: June 2007
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Purpose
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: CTA018 cream |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, 4-Arm, 12-Week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Cytochroma Inc.:
Primary Outcome Measures:
- The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
Secondary Outcome Measures:
- Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
- at least two evaluable plaques with CPSS >/= 6
- baseline PSGA >/= 2
- women of childbearing potential msut agree to use an effective form of contraception
Exclusion Criteria:
- cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- cannot have concomitant serious illness/condition that may interfere with participation in the study
- cannot have used topical therapy within 2 weeks prior to baseline visit
- cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
- cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
- cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
- cannot have a history of hypercalcemia or kidney stones
- cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
- cannot be pregnant or a nursing mother
- cannot be participating in or have participated in an interventional study within 30 days of study start
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384098
Locations
| United States, Arizona | |
| Radiant Research | |
| Tucson, Arizona, United States, 85710 | |
| United States, Arkansas | |
| Dermatology Research of Arkansas PLLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Radiant Research, Kansas City | |
| Overland Park, Kansas, United States, 66215 | |
| United States, Massachusetts | |
| Mass General/ Brigham & Women's | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Department of Dermatology, Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| UMDNJ-Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Buffalo Medical Group PC | |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Radiant Research | |
| Cincinatti, Ohio, United States, 45249 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Paddington Testing Co. | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| United States, South Carolina | |
| Radiant Research Inc. | |
| Anderson, South Carolina, United States, 29621 | |
| Palmetto Clinical Trial Services LLC | |
| Greenville, South Carolina, United States, 29607 | |
Sponsors and Collaborators
Cytochroma Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00384098 History of Changes |
| Other Study ID Numbers: | CTA018-CL-2001 |
| Study First Received: | October 2, 2006 |
| Last Updated: | June 25, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cytochroma Inc.:
|
Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013